The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

This extension study was discontinued due to financial constraints of the company. Of the 38 patients dosed, 32 did not complete all 5 doses. Of the 6 patients that completed the 5 doses, 5 patients did not have a Wk 52 MRI and therefore, no efficacy results are summarized as there is no comparison data.

Original Primary Outcome Measures ICMJE (submitted: January 4, 2008)

Evaluate changes in total number of Gd+ lesions on brain MRI [ Time Frame: Annually ]

An Open-Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of Subcutaneous Tovaxin in Subjects Previously Treated in the TERMS Study 2005-00

Brief Summary

The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.

Detailed Description

The subjects with positive myelin-reactive T cells (MRTC) in their blood during the previous TERMS study will immediately be eligible for Tovaxin production and treatment in this open label extension study. The MRTC negative subjects will be monitored quarterly for safety, MRTC reactivity, paraclinical and clinical effect. Subjects who become MRTC positive during the monitoring phase will then be eligible for Tovaxin production and treatment in this study.

Medical, psychiatric or other conditions that compromise the subject's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study.

Any significant change in the subject's medical condition after enrollment in the TERMS study which would have lead to his/her exclusion from participation in that study.

Sex/Gender

Sexes Eligible for Study:

All

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects